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Article: Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B
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TitlePeginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B
 
AuthorsMarcellin, P12
Lau, GK
Bonino, F3
Farci, P8
Hadziyannis, S11
Jin, R4
Lu, ZM10
Piratvisuth, T9
Germanidis, G1
Yurdaydin, C5
Diago, M6
Gurel, S13
Lai, MY7
Button, P
Pluck, N
 
Issue Date2004
 
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
 
CitationNew England Journal of Medicine, 2004, v. 351 n. 12, p. 1206-1217 [How to Cite?]
DOI: http://dx.doi.org/10.1056/NEJMoa040431
 
AbstractBACKGROUND: Available treatments for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B are associated with poor sustained responses. As a result, nucleoside and nucleotide analogues are typically continued indefinitely, a strategy associated with the risk of resistance and unknown long-term safety implications. METHODS: We compared the efficacy and safety of peginterferon alfa-2a (180 microg once weekly) plus placebo, peginterferon alfa-2a plus lamivudine (100 mg daily), and lamivudine alone in 177, 179, and 181 patients with HBeAg-negative chronic hepatitis B, respectively. Patients were treated for 48 weeks and followed for an additional 24 weeks. RESULTS: After 24 weeks of follow-up, the percentage of patients with normalization of alanine aminotransferase levels or hepatitis B virus (HBV) DNA levels below 20,000 copies per milliliter was significantly higher with peginterferon alfa-2a monotherapy (59 percent and 43 percent, respectively) and peginterferon alfa-2a plus lamivudine (60 percent and 44 percent) than with lamivudine monotherapy (44 percent, P=0.004 and P=0.003, respectively; and 29 percent, P=0.007 and P=0.003, respectively). Rates of sustained suppression of HBV DNA to below 400 copies per milliliter were 19 percent with peginterferon alfa-2a monotherapy, 20 percent with combination therapy, and 7 percent with lamivudine alone (P<0.001 for both comparisons with lamivudine alone). Loss of hepatitis B surface antigen occurred in 12 patients in the peginterferon groups, as compared with 0 patients in the group given lamivudine alone. Adverse events, including pyrexia, fatigue, myalgia, and headache, were less frequent with lamivudine monotherapy than with peginterferon alfa-2a monotherapy or combination therapy. CONCLUSIONS: Patients with HBeAg-negative chronic hepatitis B had significantly higher rates of response, sustained for 24 weeks after the cessation of therapy, with peginterferon alfa-2a than with lamivudine. The addition of lamivudine to peginterferon alfa-2a did not improve post-therapy response rates. Copyright 2004 Massachusetts Medical Society
 
ISSN0028-4793
2012 Impact Factor: 51.658
2012 SCImago Journal Rankings: 10.160
 
DOIhttp://dx.doi.org/10.1056/NEJMoa040431
 
ISI Accession Number IDWOS:000223861300009
 
DC FieldValue
dc.contributor.authorMarcellin, P
 
dc.contributor.authorLau, GK
 
dc.contributor.authorBonino, F
 
dc.contributor.authorFarci, P
 
dc.contributor.authorHadziyannis, S
 
dc.contributor.authorJin, R
 
dc.contributor.authorLu, ZM
 
dc.contributor.authorPiratvisuth, T
 
dc.contributor.authorGermanidis, G
 
dc.contributor.authorYurdaydin, C
 
dc.contributor.authorDiago, M
 
dc.contributor.authorGurel, S
 
dc.contributor.authorLai, MY
 
dc.contributor.authorButton, P
 
dc.contributor.authorPluck, N
 
dc.date.accessioned2007-03-23T04:38:19Z
 
dc.date.available2007-03-23T04:38:19Z
 
dc.date.issued2004
 
dc.description.abstractBACKGROUND: Available treatments for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B are associated with poor sustained responses. As a result, nucleoside and nucleotide analogues are typically continued indefinitely, a strategy associated with the risk of resistance and unknown long-term safety implications. METHODS: We compared the efficacy and safety of peginterferon alfa-2a (180 microg once weekly) plus placebo, peginterferon alfa-2a plus lamivudine (100 mg daily), and lamivudine alone in 177, 179, and 181 patients with HBeAg-negative chronic hepatitis B, respectively. Patients were treated for 48 weeks and followed for an additional 24 weeks. RESULTS: After 24 weeks of follow-up, the percentage of patients with normalization of alanine aminotransferase levels or hepatitis B virus (HBV) DNA levels below 20,000 copies per milliliter was significantly higher with peginterferon alfa-2a monotherapy (59 percent and 43 percent, respectively) and peginterferon alfa-2a plus lamivudine (60 percent and 44 percent) than with lamivudine monotherapy (44 percent, P=0.004 and P=0.003, respectively; and 29 percent, P=0.007 and P=0.003, respectively). Rates of sustained suppression of HBV DNA to below 400 copies per milliliter were 19 percent with peginterferon alfa-2a monotherapy, 20 percent with combination therapy, and 7 percent with lamivudine alone (P<0.001 for both comparisons with lamivudine alone). Loss of hepatitis B surface antigen occurred in 12 patients in the peginterferon groups, as compared with 0 patients in the group given lamivudine alone. Adverse events, including pyrexia, fatigue, myalgia, and headache, were less frequent with lamivudine monotherapy than with peginterferon alfa-2a monotherapy or combination therapy. CONCLUSIONS: Patients with HBeAg-negative chronic hepatitis B had significantly higher rates of response, sustained for 24 weeks after the cessation of therapy, with peginterferon alfa-2a than with lamivudine. The addition of lamivudine to peginterferon alfa-2a did not improve post-therapy response rates. Copyright 2004 Massachusetts Medical Society
 
dc.description.naturepublished_or_final_version
 
dc.format.extent122021 bytes
 
dc.format.extent3155 bytes
 
dc.format.mimetypeapplication/pdf
 
dc.format.mimetypetext/plain
 
dc.identifier.citationNew England Journal of Medicine, 2004, v. 351 n. 12, p. 1206-1217 [How to Cite?]
DOI: http://dx.doi.org/10.1056/NEJMoa040431
 
dc.identifier.doihttp://dx.doi.org/10.1056/NEJMoa040431
 
dc.identifier.hkuros100589
 
dc.identifier.isiWOS:000223861300009
 
dc.identifier.issn0028-4793
2012 Impact Factor: 51.658
2012 SCImago Journal Rankings: 10.160
 
dc.identifier.openurl
 
dc.identifier.pmid15371578
 
dc.identifier.scopuseid_2-s2.0-4544239807
 
dc.identifier.urihttp://hdl.handle.net/10722/43076
 
dc.languageeng
 
dc.publisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
 
dc.rightsNew England Journal of Medicine. Copyright © Massachusetts Medical Society.
 
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License
 
dc.subject.meshAntiviral agents - adverse effects - therapeutic use
 
dc.subject.meshHepatitis b, chronic - blood - drug therapy - virology
 
dc.subject.meshInterferon alfa-2a - adverse effects - therapeutic use
 
dc.subject.meshLamivudine - adverse effects - therapeutic use
 
dc.subject.meshPolyethylene glycols - adverse effects - therapeutic use
 
dc.titlePeginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B
 
dc.typeArticle
 
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<contributor.author>Farci, P</contributor.author>
<contributor.author>Hadziyannis, S</contributor.author>
<contributor.author>Jin, R</contributor.author>
<contributor.author>Lu, ZM</contributor.author>
<contributor.author>Piratvisuth, T</contributor.author>
<contributor.author>Germanidis, G</contributor.author>
<contributor.author>Yurdaydin, C</contributor.author>
<contributor.author>Diago, M</contributor.author>
<contributor.author>Gurel, S</contributor.author>
<contributor.author>Lai, MY</contributor.author>
<contributor.author>Button, P</contributor.author>
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<description.abstract>BACKGROUND: Available treatments for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B are associated with poor sustained responses. As a result, nucleoside and nucleotide analogues are typically continued indefinitely, a strategy associated with the risk of resistance and unknown long-term safety implications. METHODS: We compared the efficacy and safety of peginterferon alfa-2a (180 microg once weekly) plus placebo, peginterferon alfa-2a plus lamivudine (100 mg daily), and lamivudine alone in 177, 179, and 181 patients with HBeAg-negative chronic hepatitis B, respectively. Patients were treated for 48 weeks and followed for an additional 24 weeks. RESULTS: After 24 weeks of follow-up, the percentage of patients with normalization of alanine aminotransferase levels or hepatitis B virus (HBV) DNA levels below 20,000 copies per milliliter was significantly higher with peginterferon alfa-2a monotherapy (59 percent and 43 percent, respectively) and peginterferon alfa-2a plus lamivudine (60 percent and 44 percent) than with lamivudine monotherapy (44 percent, P=0.004 and P=0.003, respectively; and 29 percent, P=0.007 and P=0.003, respectively). Rates of sustained suppression of HBV DNA to below 400 copies per milliliter were 19 percent with peginterferon alfa-2a monotherapy, 20 percent with combination therapy, and 7 percent with lamivudine alone (P&lt;0.001 for both comparisons with lamivudine alone). Loss of hepatitis B surface antigen occurred in 12 patients in the peginterferon groups, as compared with 0 patients in the group given lamivudine alone. Adverse events, including pyrexia, fatigue, myalgia, and headache, were less frequent with lamivudine monotherapy than with peginterferon alfa-2a monotherapy or combination therapy. CONCLUSIONS: Patients with HBeAg-negative chronic hepatitis B had significantly higher rates of response, sustained for 24 weeks after the cessation of therapy, with peginterferon alfa-2a than with lamivudine. The addition of lamivudine to peginterferon alfa-2a did not improve post-therapy response rates. Copyright 2004 Massachusetts Medical Society</description.abstract>
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Author Affiliations
  1. Papageorgiou General Hospital
  2. The University of Hong Kong
  3. Ospedale Maggiore Policlinico Milano
  4. Beijing Youan Hospital
  5. Ankara Üniversitesi
  6. Hospital General Universitario de Valencia
  7. National Taiwan University Hospital
  8. Università degli Studi di Cagliari
  9. Songklanakarin Hospital
  10. Ruijin Hospital
  11. Henry Dunant Hospital
  12. Hopital Beaujon
  13. Uludağ Üniversitesi